This invention relates to an apparatus and method for treating female urinary incontinence and more particularly in humans.
The term xe2x80x9curinary incontinencexe2x80x9d refers to an involuntary leakage of urine. Urine is released from the body in an uncontrolled manner from the bladder. The lack of bladder motility during activities is central to urinary incontinence. Furthermore, there is a small region of circular muscle surrounding the middle portion of the urethra in the female called the xe2x80x9curethral sphincterxe2x80x9d. This sphincter participates in the controlled release of urine from the bladder. If the bladder becomes too immobile or if the urinary sphincter or any part of the urinary system malfunctions, the result may be urinary incontinence. Urinary incontinence can generally be characterized into two types, one of which is called xe2x80x9cstress incontinencexe2x80x9d and the other xe2x80x9curge incontinencexe2x80x9d. Stress incontinence refers to involuntary loss of urine during coughing, laughing, sneezing, jogging or other physical activity that causes a sufficient increase in intra-abdominal pressure. Urge incontinence refers to the involuntary loss of urine due to unwanted bladder contraction that is associated with a strong uncontrollable desire to urinate. xe2x80x9cMixed incontinencexe2x80x9d refers to a combination of both urge and stress incontinence. Heretofore many different types of treatment have been utilized to treat female urinary incontinence including surgical procedures which have included the injection of collagen or other material into the tissue surrounding the bladder outlet. In addition, drug therapy also has been utilized as for example drugs to treat the detrusor muscle which is a bladder wall muscle responsible for contracting and emptying the bladder without relaxing the outlet of the bladder. All of these procedures have drawbacks and also are relatively expensive. There is therefore a need for a new and improved apparatus and method for treatment of female urinary incontinence.
In general, it is an object of the present invention to provide an apparatus and method for treating female urinary incontinence which utilizes radio frequency energy for treating the urinary tract.
Another object of the invention is to provide an apparatus and method of the above character which includes a bladder outlet remodeling device and use thereof.
Another object of the invention is to provide an apparatus and method of the above character which includes a urethral sphincter remodeling device and use thereof.
Another object of the invention is to provide an apparatus and method of the above character which includes a catheter or probe with an inflatable elastomeric balloon on its distal extremity.
Another object of the invention is to provide an apparatus and method of the above character which includes an introducer and sheath particularly adapted for use in the urethra and for receiving the bladder and urethral sphincter remodeling devices.
Another object of the invention is to provide an apparatus and method of the above character which avoids major surgery and does not require surgical incisions so there is no disfiguring external scarring.
Another object of the invention is to provide an apparatus and method in which cooling liquid is provided during the procedure to minimize damage to the mucosa of the urethra.
Another object of the invention is to provide an apparatus and method of the above character which can be performed as an out-patient procedure.
Another object of the invention is to provide an apparatus and method of the above character in which only a local or regional anaesthesia is utilized.
Another object of the invention is to provide an apparatus and method of the above character which permits rapid treatment time.
Another object of the invention is to provide an apparatus and method of the above character in which there is minimal postoperative discomfort.
Another object of the invention is to provide an apparatus and method of the above character in which there is minimal or no postoperative bleeding.